Safety Needle Device

ABSTRACT

A safety needle device is disclosed having a housing configured to couple to a syringe, the housing having a proximal end, a distal end, and a housing body. A first guide path, a second guide path and a third guide path may be disposed on the housing body. A needle hub is disposed on the proximal end of the housing and a needle cannula is attached to the needle hub. The device having a retractable sheath configured to move between an initial position, a retracted position and an extended position with respect to the housing, wherein the initial position partially exposes a distal tip of the needle cannula, the retracted position fully exposes the needle cannula, and the extended position fully covers the distal tip of the needle cannula. The retractable sheath also may have a guide element. The first, second and third guide paths are configured to slidingly receive the guide element. The device also having a first locking member, a second locking member, a rotating cam disposed in the housing body, and a spring element to bias the retractable sheath to an extended state to cover the distal end of the needle cannula upon completion of an injection.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/837,008, filed on Dec. 11, 2017, issued as U.S. Pat. No. 10,589,036on Mar. 17, 2020, which claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Application No. 62/433,294, filed Dec. 13, 2016, thedisclosures of which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

The present disclosure relates generally to a safety needle device, andmore particularly to a single-use passive safety needle device having ahousing, a first guide path, a second guide path, a third guide pathintersecting the first guide path and the second guide path, a needlehub, a needle cannula, a retractable sheath, a first locking member, asecond locking member, a rotating cam, and a spring to bias theretractable sheath in a distal direction to cover the distal end of theneedle cannula.

BACKGROUND

Needle devices are used throughout the medical industry for theinjection and withdrawal of a wide variety of fluids and solutions intoand from the human body. Because of the numerous potential hazardsassociated with the handling and manipulation of bodily fluids, andparticularly blood, there are a number of known safety features that arefrequently incorporated into various types of needle devices to protectthe practitioner from accidental exposure to the needle.

Prior safety needle devices include several disadvantages includinghaving a retractable sheath requiring long stroke distances to activatethe safety feature, multi-component retraction and locking elements, andconveying an undesirable significant force against a patient's skinduring activation of the safety feature upon receiving an injection.Conventional retraction syringe assemblies often also do not incorporatereuse prevention features, and thus, the retraction mechanism of thesyringe may be reset so the syringe barrel may be reused. The reuse ofsyringe assemblies without sterilization or sufficient sterilization isbelieved to facilitate the transfer of contagious diseases. Further, theretraction features of conventional syringes may also require the userto actively activate the retraction mechanism. Accordingly, the chanceof human error in failure to activate or properly activate theretraction mechanism can lead to continued exposure of needles leadingto needle stick injuries.

Some known retracting sheath safety needle devices have been developedto include a single-use safety needle device assembly that obscures asubstantial majority or an entirety of an injection needle from viewbefore, during, and after an injection procedure. However, manyinjection procedures require that the practitioner know precisely thelocation and depth to which the needle is inserted in the patient'stissue to be sure that medication is delivered to an appropriatelocation. In addition, there exists a tendency for many users to falselyassume that they were “safe” from needle stick injuries, even in thenon-locked initial state, due to the tip of the prior art retractingsheath safety needle devices being fully covered in an unlocked state.

Thus, there is a need in the art to provide a safety needle devicehaving a passive activation mechanism that overcomes the deficiencies ofthe known retracting sheath safety needle devices and which allows forshorter stroke distance, ease of use, increased patient comfort, lowpart count, low part complexity, relatively compact design, and clearand unobstructed view of needle in an initial position.

SUMMARY

One aspect of the present disclosure pertains to a safety needle deviceincluding a housing configured to couple to a syringe, the housinghaving a proximal end, a distal end, and a housing body. The safetyneedle device also includes a first guide path, a second guide path anda third guide path disposed on the housing body, the second guide pathintersecting the first guide path and the third guide path. In one ormore embodiments, the one or more guide paths may be straight paths, andone or more guide paths may be helical. In one or more embodiments, thetwo guide paths may be straight paths, and one guide paths may behelical. In one or more embodiments, the first and third guide paths maybe straight paths, and the second guide path may be helical. A needlehub is disposed on the proximal end of the housing with a needle cannulaattached to the needle hub. The safety needle device may also include aretractable sheath having a guide element configured to move between aninitial position, a retracted position and an extended position withrespect to the housing, wherein the initial position partially exposes adistal tip of the needle cannula, the retracted position fully exposesthe needle cannula, and the extended position fully covers the distaltip of the needle cannula. The first guide path and the second guidepath are disposed on the housing body configured to receive the guideelement. The safety needle device also includes a first locking member,a second locking member; a rotating cam disposed in the housing body andconnected to the retractable sheath; and a spring element. In one ormore embodiments, the safety needle device is a single use device. Inone or more embodiments, the safety needle device is a passivelyactivated device in which the safety features provide post-injectionneedle shielding without additional intervention by the user.

In one or more embodiments, the first locking member may comprise a tabon a distal end of the retractable sheath and a locking rib on thehousing. In one or more embodiments, the first locking member maycomprise a locking rib on a distal end of the retractable sheath and atab on the housing. Movement of the retractable sheath from the initialposition to the retracted position may engage the locking rib of thehousing to the tab on the distal end of the retractable sheath. Theretractable sheath may rotate with respect to the housing duringmovement from the initial position to the retracted position. Rotationof the retractable sheath from the initial position to the retractedposition may transfer the guide element of the retractable sheath fromthe first guide path on the housing to the third guide path on thehousing via the second guide path. In one or more embodiments, the guideelement may be a peg. In one or more embodiments, the retractable sheathtranslates from the initial position to the retracted position withoutimpediment.

In one or more embodiments, movement of the retractable sheath from theretracted position to the extended position may engage the secondlocking member to a distal tip of the needle cannula. In one or moreembodiments, the second locking member may be a metal latch.

In one or more embodiments, the first locking member may inhibit reuseof the device by inhibiting rotation of the retractable sheath. Thesecond locking member may inhibit reuse of the device by inhibitingtranslation of the retractable sheath.

In one or more embodiments, the spring element biases the retractablesheath toward the extended position. The needle cannula may be obscuredfrom view when the retractable sheath is in the extended position.

In one or more embodiments, the spring element is a coil spring.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exploded view of a safety needle device accordingto a first embodiment;

FIG. 2 illustrates a perspective view of a safety needle device shown inFIG. 1 in an initial state;

FIG. 3 illustrates a sectional view of a first locking element of thesafety needle device shown in FIG. 1;

FIG. 4 illustrates another a sectional view of a first locking elementof the safety needle device shown in FIG. 1;

FIG. 5 illustrates a cross-sectional view of a safety needle deviceaccording to a first embodiment;

FIG. 6 illustrates another cross-sectional view of a safety needledevice according to a first embodiment;

FIG. 7 illustrates a perspective view of a safety needle device shown inFIG. 1 in a retracted state;

FIG. 8 illustrates a perspective view of a safety needle device shown inFIG. 1 in an extended state; and

FIG. 9 illustrates a perspective view of a safety needle deviceaccording to a first embodiment.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the disclosure, it isto be understood that the disclosure is not limited to the details ofconstruction or process steps set forth in the following description.The disclosure is capable of other embodiments and of being practiced orbeing carried out in various ways.

With respect to terms used in this disclosure, the following definitionsare provided.

As used herein, the use of “a,” “an,” and “the” includes the singularand plural.

In this disclosure, a convention is followed wherein the distal end ofthe device is the end closest to a patient and the proximal end of thedevice is the end away from the patient and closest to a practitioner.

As used herein, a “safety needle device” refers to a device having aneedle suitable for injection that includes one or more features toprevent needle stick injuries. As used herein, a “passive safety needle”refers to a safety needle device with a passive activation mechanismthat automatically covers the distal end of the needle after a patienthas been injected.

Reference to “syringe” includes syringes that are indicated for use withneedles, nozzle, tubing, or for use in flush systems. As used herein,the term “syringe” refers to a simple pump-like device consisting of aplunger rod that fits tightly in a barrel or tube. The plunger rod canbe pulled or pushed along inside the barrel, allowing the syringe totake in and expel a liquid or gas through an opening at the open end ofthe barrel. The open end of the syringe may be fitted with a needle,nozzle, or tubing to help direct the flow of fluid into and out of thebarrel. The syringe may be sterile or unsterile, depending upon theneeds of the technician.

Embodiments of the safety needle device of the present disclosureprovides a passive activation mechanism that overcomes the deficienciesof the known retracting sheath safety needle devices by allowing for ashorter distance for lockout travel, ease of use, increased patientcomfort, low part count, low part complexity, relatively compact design,and clear and unobstructed view of needle in an initial position.

FIGS. 1-9 illustrate an exemplary safety needle device 10 according tothe present disclosure. Safety needle device 10 includes a housing 20configured to couple to a syringe (not shown). Housing 20 having aproximal end 21, a distal end 22, a housing body 23 and an opening 24located on the distal end. A first guide path 30, a second guide path 32and a third guide path 34 are disposed on the housing body 23. Firstguide path 30 and third guide path 34 are generally parallel to acentral axis which extends along the housing body 23. Second guide path32 is positioned at an angle, curvature or taper relative to the axisand intersects the first guide path 30 and third guide path 34 therebyserving to separate the first guide path 30 and third guide path 34.Second guide path 32 permits the guide element 52 to shift between thefirst guide path 30 and third guide path 34. In one or more embodiments,the one or more guide paths may be straight paths, and one or more guidepaths may be helical. In one or more embodiments, the two guide pathsmay be straight paths, and one guide paths may be helical. In one ormore embodiments, the first and third guide paths may be straight paths,and the second guide path may be helical. In one or more embodiment, thefirst guide path 30, the second guide path 32 and the third guide path34 are disposed on the inner diameter of the housing body 23 to preventtampering. In one or more embodiment, the first guide path 30, thesecond guide path 32 and the third guide path 34 are disposed on theinner diameter of the housing body 23 so as not to obstruct needlecannula/needle tip visibility.

Housing 20 may be of a unitary construction or may be formed from aplurality of components. In one or more embodiments, a proximal end 21and a distal end 22 of the housing 20 can be separate components thatare joined using techniques, such as but not limited to sonic welding,adhesive, snap or press fitting, or the like.

As shown in FIG. 1, proximal end 21 of housing 20 couples to aretractable sheath 50 such that the retractable sheath 50 is configuredto move along and at least partially rotate about a central axis. Achannel and an aperture are included in the retractable sheath 50 inorder to permit the needle cannula 42 and distal tip 44 of needlecannula 42 to pass therethrough.

Needle hub 40 is disposed on the proximal end 21 of the housing 20.Needle cannula 42 is attached to the needle hub 40. The proximal end ofretractable sheath 50 includes a guide element 52 configured to movebetween an initial position, a retracted position and an extendedposition with respect to the housing 20, wherein the initial positionpartially exposes a distal tip 44 of the needle cannula 42, theretracted position fully exposes the needle cannula 42, and the extendedposition fully covers the distal tip 44 of the needle cannula 42. Theterm “retractable sheath” is intended to include any sort of tubularmember and U-shaped member. The retractable sheath 50 is dimensioned tobe compatible with the size and type of needle cannula 40 as will beappreciated by those skilled in the art. The housing 20 includes ahousing body 23 with an internal hollow region in which the retractablesheath 50 may move in the proximal and distal direction. The first guidepath 30, the second guide path 32 and third guide path 34 are disposedon the inside surface of housing body 23 configured to directing theretractable sheath 50 during movement. In one or more embodiments, thefirst path, second path and third path are configured to slidinglyreceive the guide element 52 of the retractable sheath 50.

In one or more embodiments, the proximal end 21 of the housing 20 may beconnectable to a luer connection or other fluid connector. Retractablesheath 50 is slidably mounted and movable in the distal opening 24 ofthe housing body to slidably accommodate and encase needle cannula 42projecting axially from housing 20. The distal end of retractable sheath50 is generally flush with distal end 22 of housing 20.

As shown in FIG. 1, needle cannula 42 may be connected to a needle hub40 disposed at the proximal end 21 of the housing 20 and having ablunted tip (not shown) or beveled tip (as shown in FIG. 1) at thedistal tip 44 of needle cannula 42. The needle cannula 42 is disposed inthe needle hub 40 in a manner as would be well understood in the art.The needle hub 40 may be integrally formed with the proximal end 21 ofhousing 20. Needle hub 40 may be configured to be removable orpermanently attached to the syringe, or alternatively, needle hub 40 maybe integrally formed with the syringe. For example, needle hub 40 mayinclude internal or external threads or other suitable coupling,latching, or locking features such as tabs, slots, projections,pressure/snap fits, and the like, for removably coupling the safetydevice to a syringe. In some embodiments, the housing 20 includes agenerally cylindrically reduced needle support 41 that extends axiallyfrom the needle hub 40 to support the needle cannula 42.

Housing 20 and/or needle hub 40 are in fluid communication with theneedle cannula 42 to permitting fluid to pass between the syringe andthe needle cannula 42.

The needle cannula 42 extends from the needle hub 40 disposed in thehousing 20 and extends to a distal tip 44. Distal tip 44 of the needlecannula 42 is partially exposed and protruding from the distal end ofthe retractable sheath 50 so as to be visible when the retractablesheath 50 is in an initial position, as shown in FIG. 2. The shaft ofthe needle cannula 42 is exposed from the retractable sheath 50 when theretractable sheath 50 is in a retracted position.

As illustrated in several of the drawings, most notably FIGS. 1 and 2,retractable sheath 50 is generally comprised of a tubular portion and isslidably retractable along the length of the needle cannula 42 such thata distal tip 44 of the needle cannula 42 is partially exposed andprotruding from the distal end of the retractable sheath 50 when in aninitial position so as to be visible to a user. A substantial or entireportion of needle cannula 42 is exposed when the retractable sheath 50is in its retracted position. The length of needle cannula 42 whichextends from the needle hub 40 in a distal direction is completelyencased when retractable sheath 50 is in its extended position, as shownin FIG. 8.

The needle cannula 42 in accordance with the present disclosure can beformed from conventional materials such as steel or more preferablystainless steel. It will be realized by the skilled artisan that medicalgrade plastics, composites, ceramics, or like materials can besubstituted.

The inside diameter of the retracting sheath 50 is selected so that itwill fit closely over needle cannula 42. The retracting sheath 50 may bemade of any suitable material, but preferably of a polymer which istough enough to protect needle cannula 42.

The proximal end 51 of retractable sheath 50 includes a guide element 52that extends radially outward from the proximal end of retractablesheath 50 and is configured to engage one or more paths formed on theinside surface of the housing body 23. In one or more embodiments, guideelement 52 may be an outwardly extending peg that seats against a ledgeof the distal end of the housing as shown in FIG. 2. As shown in FIGS. 1and 2, housing 20 has an opening that receives the retractable sheath50.

In one or more embodiments, retractable sheath 50 may be disposed andmovable in the housing body 23. The retractable sheath 50 is springloaded, and is supplied to the user with the retracting sheath 50partially covering the needle cannula 42 so that the distal tip of theneedle cannula is exposed and visible in an initial state, as shown inFIG. 2. In the initial state, the guide element 52 of the retractablesheath 50 is disposed in the first guide path of the housing body. Inone or more embodiments, the guide element is a peg. Upon administrationof the injection, the retractable sheath 50 moves from an initialposition whereby the distal tip 44 of the needle cannula 42 is exposedto a retracted position whereby the needle cannula is increasinglyexposed so that the needle cannula may penetrate the injection site. Asshown in FIGS. 3-7, the retractable sheath 50 rotates with respect tothe housing 20 by way of rotating cam 80 during movement from theinitial position to the retracted position.

During administration of an injection to a patient, the application offorce by the user in the distal direction causes the guide element 52 ofretractable sheath 50 to move in a proximal direction such that guideelement switches from the first guide path of the housing body to anangled second guide path of the housing body. Rotation of theretractable sheath 50 from the initial position to the retractedposition transfers the guide element 52 of the retractable sheath fromthe first guide path 30 on the housing body 23 to the third guide path34 on the housing body via the second guide path 32. In or moreembodiments, the retractable sheath translates from the initial positionto the retracted position without impediment.

As shown in FIGS. 3-6, a continued application of force by the user inthe distal direction causes rotational movement of rotation cam 80causing guide element 52 to move from the second guide path of thehousing body to a third guide path thus activating the first lockingelement 60. In one or more embodiments, the first locking element 60includes a tab on a distal end of the retractable sheath. In one or moreembodiments, the first locking element 60 further includes a locking ribon the housing. In one or more embodiments, the first locking member maycomprise a locking rib on a distal end of the retractable sheath and atab on the housing. Movement of the retractable sheath from the initialposition to the retracted position engages the locking rib of thehousing to the tab on the distal end of the retractable sheath. In someembodiments the first locking element 60 is positioned at leastpartially within an opening included in the housing body 23. In someembodiments, the first locking element 60 is generally resilient, sothat the radially inwardly disposed second ends can flex and then returnto the original position even after the ends have been radiallyoutwardly deflected. In some embodiments, the first end is larger thanthe second end, e.g. the axial locking member can taper from the firstend to the second end 54. In one or more embodiments, the first lockingmember may include a latching member, such as a hook, clasp, detent,ratchet, or other structure.

Upon activating the first locking member, a locking rib of the housingengages to a tab on the distal end of the retractable sheath therebypreventing further rotational movement of the rotation cam and thereforeensuring that the guide element does not return to its initial positionon the first guide path. Upon continued application of force by pressingretractable sheath 50 against the skin of a patient at the locationwhere it is desired to insert needle cannula 42, retractable sheath 50retracts into housing 20 allowing the injection site to be penetrated bythe needle tip and needle cannula. In one or more embodiments, the firstlocking member inhibits reuse of the device by inhibiting rotation ofthe retractable sheath.

Upon completion of an injection to the patient, the user withdraws theneedle cannula from the patient, thus causing the stored energy ofspring element 90 to allow guide element 52 of the retractable sheath 50to proceed along the third guide path 34 to allow retractable sheath 50to fully cover needle cannula 42 in the extended position. The springelement 90 biases the retractable sheath 50 in a distal direction tocover the distal tip 44 of needle cannula 42 causing activation of thesecond locking element to prevent further translational movement of theretractable sheath 50 within the housing body 23. Movement of theretractable sheath from the retracted position to the extended positionengages the second locking member to a distal tip of the needle cannula.

In one or more embodiments, the second locking element 70 is disposed onthe retractable sheath and rides along the needle cannula until thesecond locking element covers the distal tip 44 of the needle cannula 42in the extended position. In one or more embodiments, the second lockingelement 70 inhibits reuse of the safety needle device 10 by inhibitingfurther translational movement of the retractable sheath 50 within thehousing body 23. Needle cannula 42 is obscured from view when theretractable sheath is in the extended position. As shown in FIG. 8, asthe injection is completed and the distal tip 44 of needle cannula 42 ispulled from injection site, the stored force of spring element 90 causesthe retracting sheath 50 to extend, and at the end of the stroke, asecond locking member extends over the distal tip 44 of the needlecannula 42 to lock the retractable sheath 50 thereby completing apassive safety lock-out. In one embodiment, the second locking member isa metal clip.

Spring element 90 includes a proximal end, a main body, and a distalend. In one or more embodiments, as shown in FIG. 1, spring element 90comprises a compression or coil spring. The spring element 90 biases theretractable sheath toward the extended position.

FIG. 1 illustrates a safety needle device 10 that may be removablycoupled to a standard or specially configured syringe (not shown).Although the illustrated safety needle device 10 is configured to becoupled to and removed from a syringe, the safety needle device 10 mayinstead be integrally formed with the syringe. The syringe is generallyof a known type suitable for the withdrawal and injection and/oraspiration of fluids or other solutions by way of the safety needledevice 10. In one or more embodiments, the safety needle device is asingle use device. In one or more embodiments, the safety needle deviceis a passively activated device in which the safety features providepost-injection needle shielding without additional intervention by theuser.

Referring now to FIG. 2, the safety needle device 10 is illustrated inan initial state wherein the retractable sheath 50 is in a partiallyretracted configuration. Further retraction of the retractable sheath 50is generally initiated by a user applying pressure on the safety needledevice 10 and/or syringe in the distal direction, which therebyencourages the retractable sheath 50 proximally against the bias of thespring element 90. This retraction of the retractable sheath 50 in turnfurther exposes the distal tip 44 of the needle cannula 42 and initiatespenetration by the needle cannula 42 into the patient's skin. The guideelement 52 of the housing 14, which is initially positioned in the firstguide path 30, directs the retractable sheath 50 to immediately movetoward the second guide path 32. As the retractable sheath 50 movesproximally, the guide element 52 passes through the second guide path 32thereby encouraging the retractable sheath 50 to rotate on the rotatingcam about the axis. Upon reaching the intersection of the second andthird guide paths, the guide element 52 may not return to the firstguide path 30 due to the rotating cam engaging the first locking membersuch that a locking rib of the housing engages the tab on the distal endof the retractable sheath to prevent further rotation of the rotatingcam and thus preventing the guide member from returning to the firstguide path 30.

In one or more embodiment, spring element 90 engages and extends betweenthe proximal end of the retractable sheath and the proximal end of thehousing. The spring biases the retractable sheath 50 toward an initialposition in which the guide element 52 of the retractable sheath 50 isbiased into engagement with the first guide path located at the distalend of the housing body 23 allowing the distal tip 44 of the needlecannula 42 to be exposed and visible in the initial position. Theretractable sheath 50 completely covers the distal tip 44 of the needlecannula 42 in the extended position. Many types of springs may beemployed, such as but not limited to a helical coil spring, conicalspring, wave-spring, Belleville washer, or the like. In someembodiments, the spring element 90 is configured to facilitateretraction of the retractable sheath 50 by a user applying distalpressure to the syringe and/or the safety needle device 10 with just onehand.

In one or more embodiments, as shown in FIGS. 3, 4, 5 and 6, rotatingcam 80 includes having an outwardly extending portion from which animpeding member, such as a tab or other resilient member, extends, e.g.circumferentially, radially, axially, a combination thereof, or thelike. In one or more embodiments, the end of the impeding member of therotating cam may be shaped as a radially outwardly extending wedgehaving an inclined face or flat face which interacts with a wedge-shapedrotational locking member, e.g. an axial rib, extends radially inwardlyfrom the inner surface of the housing and includes an inclined face anda generally flat face. In one or more embodiments, the inclined face ofthe wedge may be configured to be in the opposite direction as theinclined face. The end and rotational locking member may bewedge-shaped, hemispherical, frusto-conical, or the like. In someembodiments, the axial length of the rotational locking member isgreater than the axial length of the impeding member. In someembodiments, at least a portion of the impeding member is configured tofit into at least a portion of the rotational locking member or viceversa. For example, the impeding member can comprise a tab configured tofit within a slot included in the rotational locking member.

Safety needle device 10, and components thereof, can be formed usingmany manufacturing processes sufficient to provide the desired shape ofthe components. In some embodiments one or more components are made by amolding process, such as but not limited to injection molding,compression molding, blow molding, transfer molding, or similar. In someembodiments, one or more components are formed by forging, machining,casting, stamping, extrusion, a combination thereof, or the like.

In many embodiments, the safety needle device 10 is constructed from abiocompatible material. In some arrangements one or more of thecomponents of the safety needle device 10 are plastic (e.g.polyurethane, etc.) or metal (e.g., stainless steel, etc.). In someembodiments, the housing 14 and/or the retractable sheath 50 areconstructed of materials that are either translucent or opaque.

In some embodiments, movement of the retractable sheath 50 automaticallyengages a first locking element 60 and second locking element 70. Insome embodiments, movement of the retractable sheath 50 from an aboutfully retracted position to an about fully extended positionautomatically prevents or inhibits reuse of the safety needle device 10.

In some embodiments, the safety needle device may manufactured byforming the housing 20 with the needle support 41, the distal opening24, the first guide path 30, second guide path 32 and third guide path34. In embodiments in which housing 20 comprises multiple pieces, themanufacturing process can include the step of assembling the housing 20.A retractable sheath is formed having guide element 52 which is alignedwith first guide path 30. The retractable sheath 50 is slidingly movedthrough the distal opening 24. The needle cannula 42 is coupled with theneedle support 41 of the housing 20. The spring element 90 is insertedinto the housing body 23 and positioned to bias the retractable sheath50.

As shown in FIG. 7, as the retractable sheath 50 continues to retractinto the housing body 23, to further expose the needle cannula 42 to alength 500, the guide element 52 shifts from the second guide path 32 tothe third guide path 34, thus further rotating the retractable sheath 50with respect to the housing 20. Upon withdrawal of the needle cannula 42from the patient, the stored spring energy of the spring element 90 todistally extend the retractable sheath 50. As the retractable sheath 50distally extends, it covers the needle cannula 42 into the channel ofthe hub body thereby covering the distal end of the needle cannula 42.The distal movement of the retractable sheath 50 also slides the guideelement 52 along the third guide path 34. The engagement of the firstlocking member inhibits or prevents counter-rotation of the retractablesheath 50, which in turn prevents the guide element 52 from shiftingback into the first guide path 30 at intersection between the firstguide path 30 and the second guide path 32.

As shown in FIG. 8, upon reaching the retractable sheath 50 reaching thedistal tip 44 of the needle cannula 42, the second locking element 70moves distally over the distal tip to cover the distal tip 44 of theneedle cannula 4 to prevent reuse of the safety needle device 10. Theretractable sheath 50 has been fully extended and fully covers theneedle cannula 42. The second locking element 70 thus presents aphysical stop to inhibit the retractable sheath 50 from being proximallyretracted again.

Housing 20 couples to retractable sheath 50 to allow retractable sheath50 to translate along and at least partially rotate about the axis.

Therefore, embodiments of the present disclosure utilize guide element52 on the retractable sheath traveling along a first guide path 30,second guide path 32 and third guide path 34 disposed inside housing 20.Once injection begins, the guide element 52 on the retractable sheath 50travels along the a first guide path 30, second guide path 32 and thirdguide path 34 rotating the retractable sheath from an initial positionto a second position as it moves axially. Once rotation is completed, afirst locking element 60 comprising two locking tabs at the top of theretractable sheath 50 snap into ribs within the housing 20. The twolocking tabs serve to keep retractable sheath 50 from rotating back tothe initial position ensuring that final lockout with second lockingelement 70 will occur. At this point, the user can continue to insertthe needle to the desired depth in the patient and the retractablesheath 50 will move axially within the housing path. Upon removal of theneedle cannula, spring element 90 within the system will push theretractable sheath 50 down the third guide path 34 to a final positionand the second locking element 70 will automatically cover the distaltip 44 of the needle cannula 42 thereby passively protecting the userfrom needle stick injury.

Stroke length is the sum of needle cannula length and retractable sheath50 lockout travel. The distance between proximal end of retractablesheath 50 and distal tip 44 of needle cannula 42 is a stack-up oftolerances and safety margin to insure needle stick injury (NSI) isprevented following use.

In one or more embodiments, overall length of the safety needle devicemay be reduced when the spring element is allowed to collapse insideboth the retractable sheath 50 and housing 20. Thus reducing overalllength by the solid height and subsequently lowering forces applied to apatient's skin.

In one or more embodiments, overall length of the safety needle devicemay also be reduced by using telescoping components.

As shown in FIG. 9, in one or more embodiments, the safety needle device10 can include a cap 100 that is removably coupled to the housing 20 toreduce or prevent contamination of the needle cannula during shippingand storage of the safety needle device 10. The cap 100 is generallykept in the closed position until just prior to an injection and/oraspiration procedure, at which time the cap 100 removed from the housing20. In some embodiments, cap 100 is configured to assist in properlydrawing a dose from a vial.

Any suitable caps or packaging comprising a safety feature may be usedin conjunction with the safety needle device disclosed herein. Anysuitable caps or packaging comprising a safety feature may be used inconjunction with the safety needle device disclosed herein. Types ofsafety features vary in structure and mechanics but exemplary caps orpackaging include, but are not limited to, those described in commonlyowned, U.S. Patent Application Ser. Nos., 62/433,044, 62/433,526 and62/433,297, the disclosures of which are incorporated herein byreference in their entireties.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “various embodiments,” “one or more embodiments” or “anembodiment” means that a particular feature, structure, material, orcharacteristic described in connection with the embodiment is includedin at least one embodiment of the disclosure. Thus, the appearances ofthe phrases such as “in one or more embodiments,” “in certainembodiments,” “in various embodiments,” “in one embodiment” or “in anembodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the disclosure.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the disclosure herein provided a description with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thedisclosure. It will be apparent to those skilled in the art that variousmodifications and variations can be made to the present disclosurewithout departing from the spirit and scope thereof. Thus, it isintended that the present disclosure include modifications andvariations that are within the scope of the appended claims and theirequivalents.

What is claimed is:
 1. A safety needle device, comprising: a housingconfigured to couple to a syringe, the housing having a proximal end, adistal end, and a housing body; a first guide path, a second guide pathand a third guide path disposed on the housing body, the second guidepath intersecting the first guide path and the third guide path, thefirst guide path located at the distal end of the housing body; a needlehub disposed on the proximal end of the housing; a needle cannulaattached to the needle hub, the needle cannula having a distal tip; aretractable sheath having a guide element configured to move between aninitial position, a retracted position and an extended position withrespect to the housing, wherein the guide element is biased intoengagement with the first guide path allowing the distal tip of theneedle cannula to be exposed in the initial position; a first lockingelement, the first locking element comprising a tab on a distal end ofthe retractable sheath and a locking rib on the housing; a secondlocking element; a rotating cam disposed in the housing body; and aspring element; wherein movement of the retractable sheath from theinitial position to the retracted position engages the locking rib ofthe housing to the tab on the distal end of the retractable sheath,thereby preventing further rotation of the rotating cam and thuspreventing the guide member from returning to the first guide path. 2.The safety needle device of claim 1, wherein the retractable sheathrotates with respect to the housing during movement from the initialposition to the retracted position.
 3. The safety needle device of claim1, wherein the guide element extends radially outward from the proximalend of the retractable sheath.
 4. The safety needle device of claim 1,wherein the first locking element is tapered.
 5. The safety needledevice of claim 1, wherein the first locking element is passivelyactivated.
 6. The safety needle device of claim 1, wherein theretractable sheath rotates with respect to the housing during movementfrom the initial position to the retracted position.
 7. The safetyneedle device of claim 6, wherein rotation of the retractable sheathfrom the initial position to the retracted position transfers the guideelement of the retractable sheath from the first guide path on thehousing to the third guide path on the housing via the second guidepath.
 8. The safety needle device of claim 1, wherein the second lockingelement comprises a metal latch.
 9. The safety needle device of claim 1,wherein the second locking element is passively activated.
 10. A safetyneedle device of claim 1, wherein movement of the retractable sheathfrom the retracted position to the extended position engages the secondlocking element to a distal tip of the needle cannula.
 11. The safetyneedle device of claim 1, wherein the first locking element inhibitsreuse of the safety needle device by inhibiting rotation of theretractable sheath.
 12. The safety needle device of claim 1, wherein thesecond locking element inhibits reuse of the safety needle device byinhibiting translation of the retractable sheath.
 13. The safety needledevice of claim 1, wherein the spring element biases the retractablesheath toward the extended position.
 14. The safety needle device ofclaim 1, wherein the retractable sheath translates from the initialposition to the retracted position without impediment.
 15. The safetyneedle device of claim 1, wherein the needle cannula is obscured fromview when the retractable sheath is in the extended position.
 16. Thesafety needle device of claim 1, wherein the initial position partiallyexposes a distal tip of the needle cannula, the retracted position fullyexposes the needle cannula, and the extended position fully covers thedistal tip of the needle cannula, the first guide path and the secondguide path disposed on the housing body configured to receive the guideelement.
 17. The safety needle device of claim 1, further comprising acap removably coupled to the housing.
 18. A safety needle device,comprising: a housing configured to couple to a syringe, the housinghaving a proximal end, a distal end, and a housing body; a first guidepath, a second guide path and a third guide path disposed on the housingbody, the second guide path intersecting the first guide path and thethird guide path; a needle hub disposed on the proximal end of thehousing; a needle cannula attached to the needle hub, the needle cannulahaving a distal tip; a retractable sheath having a guide elementconfigured to move between an initial position, a retracted position andan extended position with respect to the housing, wherein the guideelement is biased into engagement with the first guide path allowing thedistal tip of the needle cannula to be exposed in the initial position;a locking rib on a distal end of the retractable sheath; a tab on thehousing; a metal latch disposed on the retractable sheath; a rotatingcam disposed in the housing body; and a spring element.
 19. The safetyneedle device of claim 18, wherein the spring element is a coil spring.20. The safety needle device of claim 18, further comprising a capremovably coupled to the housing.